Trial Outcomes & Findings for Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT) (NCT NCT04229134)
NCT ID: NCT04229134
Last Updated: 2026-09-02
Results Overview
Post-treatment follow-up retention rates and their 95% confidence intervals. These will be compared to 80%, which is the lowest rate obtained in a behavioral pain trial and comparable to peer support interventions
COMPLETED
NA
4 participants
3 months post baseline
2026-09-02
Participant Flow
Participant milestones
| Measure |
Pilot Arm: Project CONNECT
8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)
Baseline characteristics by cohort
| Measure |
Pilot Arm: Project CONNECT
n=4 Participants
8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain
|
|---|---|
|
Age, Continuous
|
41.67 Years
STANDARD_DEVIATION 12.58 • n=136 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 3 months post baselinePost-treatment follow-up retention rates and their 95% confidence intervals. These will be compared to 80%, which is the lowest rate obtained in a behavioral pain trial and comparable to peer support interventions
Outcome measures
| Measure |
Pilot Arm: Project CONNECT
n=4 Participants
8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain
|
|---|---|
|
Feasibility: Retention
|
0 Percent of participants retained
Interval 0.0 to 0.75
|
PRIMARY outcome
Timeframe: 6 months post-baselineLong-term follow-up retention rates and their 95% confidence intervals. These will be compared to 80%, which is the lowest rate obtained in a behavioral pain trial and comparable to peer support interventions
Outcome measures
| Measure |
Pilot Arm: Project CONNECT
n=4 Participants
8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain
|
|---|---|
|
Feasibility: Long-term Retention
|
0 percent participants retained
Interval 0.0 to 0.75
|
SECONDARY outcome
Timeframe: 3 months post baselineRates of successful dyad connection will be compared to 80% (comparable to other Reciprocal Peer Support interventions)
Outcome measures
| Measure |
Pilot Arm: Project CONNECT
n=4 Participants
8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain
|
|---|---|
|
Feasibility: Dyad Connection
|
0 percentage of participants paired
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: 3 months post baselinePopulation: There were no participants who were successfully paired and enrolled in the intervention so participants did not complete diaries
Nightly assessment completion rates and their 95% confidence intervals will be compared to other Veteran behavioral pain trials demonstrating an 85% completion rate.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post baselinePopulation: There were no participants paired, thus they did not proceed to the intervention. Because of this, there was no data collected on skill practice
Skill practice rates and their 95% confidence intervals will also be compared to 65% consistent with rates reported in similar pain trials.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post baselinePopulation: There were no participants paired, thus they did not proceed to the intervention. Because of this, there was no data collected on acceptability or satisfaction
Mean intervention satisfaction and credibility ratings and their 95% confidence intervals will be compared to 80% which is the standard for behavioral pain trials
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post baselinePopulation: There were no participants paired, thus they did not proceed to the intervention. Because of this, there was no data collected on the acceptability of the peer matching
Favorable experience with peer ratings and their 95% confidence intervals will be compared with 80% which is comparable to other reciprocal peer support interventions
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months post baselinePopulation: There were no participants paired, thus they did not proceed to the intervention. Because of this, there was no data collected
A responder analysis will be completed to determine percent of subjects achieving a clinically meaningful reduction in pain intensity, pain interference and depression. For both the Brief Pain Inventory Pain Intensity and Pain Interference subscales, a 30% reduction is defined as clinically meaningful. For depressive symptoms, a reduction of 5 points on the Patient Health questionnaire-8 is considered clinically meaningful
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months post baselinePopulation: There were no participants paired, thus they did not proceed to the intervention. Because of this, there was no data collected on skill practice
A responder analysis will be completed to determine percent of subjects achieving a clinically meaningful reduction in pain intensity, pain interference and depression. For both the Brief Pain Inventory Pain Intensity and Pain Interference subscales, a 30% reduction is defined as clinically meaningful. For depressive symptoms, a reduction of 5 points on the Patient Health questionnaire-8 is considered clinically meaningful
Outcome measures
Outcome data not reported
Adverse Events
Pilot Arm: Project CONNECT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place